The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Teleflex Steerable Guidewire.
| Device ID | K871850 |
| 510k Number | K871850 |
| Device Name: | TELEFLEX STEERABLE GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | Teleflex Medical, Inc. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Richard Gardner |
| Correspondent | Richard Gardner Teleflex Medical, Inc. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-12 |
| Decision Date | 1988-01-27 |